FDA Authorizes New COVID-19 Vaccine Without Clinical Data

The U.S. Food and Drug Administration (FDA) has authorized a new COVID-19 vaccine from Novavax, giving Americans an alternative to shots from Moderna and Pfizer.
Novavax’s protein-based vaccine will be available soon after regulators granted emergency authorization to the Maryland-based company for the product.
FDA officials said that animal testing data supported the decision.
Critics say that the agency should not be making an assertion about safety and effectiveness in the absence of clinical trial data.
“The assertion rings hollow when FDA has not required manufacturers of the mRNA biological [products] to provide scientific evidence to the public that safety and effectiveness has been demonstrated,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times previously via email.
JN.1 was displaced in the spring by KP.3 and other variants, according to sequencing performed by the U.S. Centers for Disease Control and Prevention.
The Pfizer and Moderna vaccines target KP.3.
Because Novavax’s vaccine is built on different technology, it takes longer to manufacture than the mRNA shots. Company officials told FDA advisers over the summer that they were planning to continue manufacturing a JN.1-based vaccine and believed it would perform well against KP.3 and other strains from the JN.1 lineage.
The authorization is for people aged 12 and older. People who have never received a vaccine can get two doses of Novavax’s vaccine about three weeks apart. People who have received a vaccine before can get a single dose.
The Moderna and Pfizer vaccines are available for individuals who are at least 6 months old.
The CDC is recommending vaccination for all people aged 6 months and older.
COVID-19 levels have plummeted since early 2022, although data from wastewater and other sources have indicated a recent uptick.